Research Scientist, Analytical R&D

As a member of the team at Apotex Inc., you will be responsible for executing analytical method optimization, development, validation, and verification of various analytical test methods. Your role will involve working with Compendia, in-house developed methods, site transfer methods, regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes (SDC), and other procedural updates. You will also be involved in the preparation of method validation/verification protocols and reports. Your key responsibilities will include: - Executing method optimization and development studies - Conducting method validation and verification of in-house methods, Compendia, SDC, MLCM, and Cleaning Analytical methods while adhering to regulatory procedures - Preparing method verification and method transfer protocols and reports - Analyzing and reporting method transfer data - Performing analytical studies related to regulatory queries and submission requirements - Ensuring all work is carried out in compliance with established regulatory and safety requirements - Overseeing activities in the Quality Control Laboratory, including cGLP, documentation, and implementation of the departmental quality system - Working collaboratively and safely as a team member to achieve outcomes - Demonstrating behaviors aligned with organizational values: Collaboration, Courage, Perseverance, and Passion - Maintaining personal adherence to compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies - Undertaking any other relevant duties as assigned In terms of qualifications, you should possess: Education: - Minimum MSc/BPharm or an equivalent degree Knowledge, Skills, and Abilities: - Proficiency in Microsoft Office (Word, Excel) - Understanding of method optimization/development activities - Ability to effectively complete work activities within specified timelines - Capable of performing multi-parameter analysis on HPLC instruments Experience: - Minimum of 3 to 6 years of experience in the GMP regulated Pharmaceutical Industry At Apotex, we are dedicated to creating an inclusive and accessible work environment where all employees are valued, respected, and supported. We offer accommodation for applicants with disabilities during the recruitment process. If you are selected for an interview or testing, please inform us if you require any accommodations.,